Manager – Case Processing
Location: Noida, India
Category: Consulting / Pharmacovigilance
Job Type: Full-Time
Experience Required: Minimum 10 Years
Job ID: R2522051
About Cencora
Cencora is a global leader in healthcare services, dedicated to ensuring patient safety and regulatory compliance across pharmaceuticals and clinical trials. Our mission is to deliver innovative pharmacovigilance solutions that improve the health outcomes of people and animals worldwide. Join our team to make a meaningful impact in drug safety and clinical operations.
Position Overview
The Manager – Case Processing will lead pharmacovigilance case management operations, ensuring high-quality case processing, regulatory compliance, and effective team management. This leadership role involves oversight of case workflows, project coordination, team mentoring, and quality control, contributing to Cencora’s reputation for excellence in drug safety and PV services.
Key Responsibilities
Leadership & Team Management
Lead and manage a team of PV associates, overseeing workload allocation, quality, and compliance.
Serve as the line manager for assigned staff, including recruitment, goal-setting, performance appraisals, and training compliance.
Mentor new joiners and provide ongoing guidance on PV processes and company SOPs to enhance team capabilities.
Case Processing & Quality Oversight
Oversee triage, processing, and quality control of ICSRs, including data entry, documentation, and submission to Health Authorities and client partners.
Ensure adherence to regulatory timelines for expedited reporting and follow-up requests.
Identify potential risks in case processing workflows and implement mitigation strategies to enhance compliance and efficiency.
Prepare and review QA documents, including SDEAs, SOPs, working instructions, templates, and project metadata files.
Regulatory Compliance & Audits
Ensure full compliance with global pharmacovigilance standards, ICH, GCP, EMA, FDA, and other regulatory guidelines.
Represent the PV department during client audits, regulatory inspections, and for-cause assessments.
Interface with internal stakeholders such as VDC office, QPPV office, compliance, and other departments to maintain regulatory alignment.
Project Coordination & Reporting
Manage project execution, resource allocation, and monthly client invoicing.
Develop and implement workflow procedures, case processing strategies, and dashboards to monitor operational performance.
Prepare comprehensive management reports and visual analytics for senior leadership.
Qualifications
University degree in Life Sciences, Pharmacy, or related discipline.
Minimum 10 years of experience in pharmacovigilance, drug safety, and case processing.
Skills & Competencies
Strong leadership, mentoring, and team management abilities.
Excellent written and verbal communication skills.
Proven ability to analyze issues, provide solutions, and improve processes.
Strong organizational skills and attention to detail.
Experience in handling complex PV projects and regulatory submissions.
Why Join Cencora
Opportunity to lead and mentor PV teams in a globally recognized organization.
Gain exposure to regulatory audits, case processing strategies, and pharmacovigilance operations.
Work in a dynamic, collaborative environment committed to professional growth and excellence.
Equal Opportunity & Accessibility
Cencora is an equal opportunity employer, committed to diversity, inclusion, and providing reasonable accommodations during the recruitment process.
Apply now to take your career to the next level in pharmacovigilance, case processing, and drug safety management.
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